Assays

Roche receives FDA 510(k) clearance for the first blood test in the U.S. measuring Lp(a) in molar units

Jan. 30, 2025

The Roche Diagnostics Tina-quant Lipoprotein (a) Gen.2 Molarity assay is an in-vitro test measuring lipoprotein (a) in a person’s bloodstream (serum and plasma), and will be broadly...

Assays

Roche receives FDA clearance with CLIA waiver for cobas liat molecular tests to aid in diagnosing sexually transmitted infections at the point of care

LABline

Jan. 24, 2025

Assays

Product Focus- Assays/Controls

MLO Staff

Dec. 23, 2024

Sponsored Content

Assays

Value of a Chromatogram in Hemoglobin A1C Testing

Nov. 13, 2024

PIQRAY® is a registered trademark of Novartis AG. VECTIBIX® is a registered trademark of Immunex Corporation. BRAFTOVI® is a registered trademark of Array BioPharma Inc. in the United States and various other countries. ERBITUX® is a registered trademark of ImClone LLC, a wholly owned subsidiary of Eli Lilly and Company. MEKINIST® is a registered trademark of Novartis AG Corporation Switzerland. KEYTRUDA® is a registered trademark of Merck. LENVIMA® (lenvatinib) is a registered trademark used by Eisai Inc. under license from Eisai R&D Management Co., Ltd.

Assays

Caris Life Sciences receives FDA approval for MI Cancer Seek as a companion diagnostic (CDx) test

LABline

Nov. 8, 2024

yourgene_cystic_fibrosis_base_assay_ivdr

Assays

Yourgene Health Cystic Fibrosis Base assay receives IVDR accreditation

LABline

Oct. 18, 2024

Sponsored Content

Video

Accessible and Accurate Testing Solutions from Home to Lab by Sekisui Diagnostics

Sept. 20, 2024

Accessible and Accurate Testing Solutions from Home to Lab by Sekisui Diagnostics.Sponsored by:

Assays

QIAGEN expands QIAcuity digital PCR offering with over new 100 assays via GeneGlobe platform

LABline

Sept. 19, 2024

QIAGEN adds over 100 new validated QIAcuity digital PCR assays for cancer research, inherited genetic disorders, infectious disease surveillance, and other applications.

Sponsored Content

Video

CLSI’s Focused on Preparing Labs for Change

Sept. 11, 2024

Clinical and Laboratory Standards Institute (CLSI) CEO Barb Jones shares how the global nonprofit’s standards, training and educational offerings prepare labs to meet the...

Assays

VITROS syphilis assay now available on VITROS 3600 immunodiagnostic system, VITROS 5600 and VITROS XT 7600 integrated systems in the U.S.

LABline

Aug. 30, 2024

QuidelOrtho receives FDA 510(k) clearance for its VITROS syphilis assay.

Sponsored Content

Video

Flexible Syndromic Solutions for Respiratory Diagnostics 

Aug. 30, 2024

Michelle Tabb and Giulia Amicarelli of Diasorin discuss the current challenges for respiratory testing and how customizable syndromic testing is contributing to diagnostic stewardship...

Assays

Bio-Rad launches new Specialty Immunoassay Plus controls

LABline

Aug. 23, 2024

Next generation of independent specialty IA quality controls features procalcitonin in liquid format.

Assays

Thermo Fisher Scientific announces extended 510k Clearance of Freelite Assays for evaluation of MGUS, a precursor to multiple myeloma

LABline

July 30, 2024

Thermo Fisher update.

Assays

Diasorin receives FDA de-Novo grant for the Simplexa C. auris Direct assay on the LIAISON MDX instrument

LABline

July 19, 2024

Simplexa C. auris Direct is a is a real-time polymerase chain reaction assay run on the LIAISON MDX instrument for the direct in vitro qualitative detection of Candida auris DNA...